Kornimate/medical-research-clean huggingface dataset:
tolerability of acthar for the treatment of multiple sclerosis in relapses (tams)

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: tolerability of acthar for the treatment of multiple sclerosis relapses (tams)

we propose to conduct a prospective, single-center, open-label, single-arm study comparing tolerability of acthar versus oral prednisone in the treatment of ms relapses. potential subjects will be identified during routine clinical evaluations. if patient is determined to be having a study-defined ms relapse, they will be invited to participate in this study. after consent is obtained, the patient will complete the first page of the arms survey. if prior steroid use was deemed tolerable then only the first page of the arms will be collected and analyzed and these patients will complete their participation in the trial. their data from the arms will provide an estimate as to the number of patients who self-report tolerability and efficacy issues with steroids. however, if patients self-report prior steroid intolerability, then they will advance into the acthar treatment arm of the trial.

Eligibility criteria:
inclusion criteria: 1. subjects who have volunteered and consented to participate in the study. 2. subjects who have no contraindication to taking high dose, oral prednisone or acthar. 3. male or female subjects age 18 or greater years of age. 4. subjects with relapsing remitting multiple sclerosis (rrms) based on 2010 mcdonald criteria. 5. subjects without an active infection (note: if a patient is found to have an uncomplicated uti and agrees to start on appropriate antibiotic treatment, they can continue in the study). 6. subjects who are experiencing a protocol defined ms relapse within two weeks of relapse onset. 7. subjects who are able and willing to sign a consent form. exclusion criteria: 1. subjects who are less than 18 years of age. 2. subjects with any contraindication to taking acthar. 3. subjects with an active infection other than an uncomplicated urinary tract infection (uti) (subjects determined to have a uti who agree to be treated with appropriate antibiotics will not be excluded). 4. subjects with an immune deficiency. 5. subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis. 6. subjects who are pregnant or breastfeeding. 7. subjects who are unable or unwilling to sign consent form. 8. patient is unable or unwilling to participate in phone and clinic follow up. 9. other factors that in the opinion of the principal investigator would exclude the subject from participation in the study.
clinical and radiographic evaluation of oral findings in children of multiple and single births

Conditions: Oral Findings in Children of Multiple and Single Births; Radiographic Evaluation of Oral Findings in Children of Multiple and Single Births

Summary: clinical and radiographic evaluation of oral findings in children of multiple and single births

in this study, the study groups comprised mz and dz twin pairs, triplets and singletons between the ages of 2 and 17 who attended the department of pediatric dentistry at suleyman demirel university between january 2018 and september 2020. twins and triplets who had developmental anomalies such as cleft lip and palate, premature tooth loss, systemic diseases or syndromes that could influence oral health or had already undergone or were undergoing orthodontic therapy, as well as those whose family did not give consent, were excluded from the study. all children were assessed by the same experienced pedodontist (e.o.) to avoid interexaminer variability. the oral examination was performed using sterile mouth mirror and probe. the prevalence of dental caries was recorded using dmft index (decayed, missing and filled teeth) in primary dentition and dmft index (decayed, missing and filled teeth) in permanent dentition. when evaluating patients over 6 years old, the missing tooth component was not included in the primary dft scores. oral hygiene practices, such as tooth brushing frequency and the children's past or present oral habits (digit sucking, nail biting, tongue thrust, bruxism, lip biting, pencil biting, cheek biting and mouth breathing), were also recorded. the primary molar relationships were evaluated as flush terminal plane and mesial and distal step. the permanent molar relationships were recorded as class i, class ii (division 1 and 2) and class iii. occlusal traits such as increased overjet, deep bite, open bite and anterior and posterior crossbite were recorded as present (1) or absent (0) with the help of a dental probe

Eligibility criteria:
inclusion criteria: * twins, triplets and singletons who had not * developmental anomalies such as cleft lip and palate * premature tooth loss * systemic diseases or syndromes that could influence oral health * already undergone or were undergoing orthodontic therapy exclusion criteria: * twins, triplets and singletons who had * developmental anomalies such as cleft lip and palate * premature tooth loss * systemic diseases or syndromes that could influence oral health * already undergone or were undergoing orthodontic therapy * those whose family did not give consent

Keywords: dental caries multiple births oral habits singletons twins
a phase i study of tas-102 in patients with advanced solid tumors with renal impairment

Conditions: Advanced Solid Tumors

Summary: study to evaluate the safety, tolerability, and pharmacokinetics of tas-102 in patients with advanced solid tumors and varying degrees of renal impairment.

this is a phase 1, open-label study to evaluate the safety, tolerability, and pharmacokinetics of tas-102 in patients with advanced solid tumors with varying degrees of renal impairment. the study is conducted in 2 parts: the pharmacokinetic part (cycle 1) and the extension part (cycles 2 and beyond). patients may continue to receive treatment with tas-102 during the study extension part only after completion of the pharmacokinetic part.

Eligibility criteria:
inclusion 1. has provided written informed consent 2. has advanced solid tumors (excluding breast cancer) 3. has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis 4. ecog performance status of ≤2 5. is able to take medications orally 6. has adequate organ function 7. women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. males must agree to adequate birth control. exclusion 1. certain serious illnesses or medical condition(s) 2. has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration 3. has received tas-102 4. has unresolved toxicity of greater than or equal to ctcae grade 2 attributed to any prior therapies 5. is a pregnant or lactating female

Keywords: renal kidney diseases urologic diseases renal insufficiency renal impairment pharmacokinetics advance solid tumor creatinine clearance kidney neoplasms renal tumor kidney urology pharmacologic action
alk33-005: a study of alks33 (rdc-0313) in adults with alcohol dependence

Conditions: Alcohol Dependence

Summary: this study will evaluate the safety and efficacy of alks33 (rdc-0313) compared with placebo in adults with alcohol dependence. there will be 11 study visits conducted over a period of about 4 months. the study period includes a screening visit, a 12-week treatment period, and a follow-up visit.

this is a multi-center, randomized, double-blind, placebo-controlled study. a 3-stage adaptive design will be used. following screening, eligible subjects will be randomized equally to 1 of 4 groups (alks33 \[rdc-0313\] \[1, 2.5, or 10 mg\], or matching placebo).

Eligibility criteria:
inclusion criteria: * 18 years of age or older * current diagnosis of alcohol dependence, with recent heavy drinking (eg, 5 drinks per day for men and 4 drinks per day for women) * a noncustodial stable residence and a telephone * women having reproductive potential must agree to use an approved method of contraception for the duration of the study * ability to stop drinking prior to receiving study drug exclusion criteria: * pregnancy and/or current breastfeeding * past or present history of an aids-indicator disease * current dependence on any drugs (exclusive of nicotine, caffeine, or alcohol) * positive urine drug screen for benzodiazepines (unless used for a short-term basis during alcohol detoxification), opioids, amphetamines/ methamphetamines or cocaine at visits 1 and 2 * clinically significant medical condition * current or anticipated need for prescribed opioid medication during the study period * use of naltrexone within 60 days prior to screening * current need for antidepressants (within 30 days prior to entry) * participation in a clinical trial of a pharmacological agent within 30 days prior to screening * parole or probation or pending legal proceedings that have the potential for incarceration during the study period
confirmatory trial for alleviating fatigue in multiple sclerosis

Conditions: Multiple Sclerosis; Fatigue

Summary: cafe-ms will assess the effectiveness of two online programs for fatigue in multiple sclerosis (ms). although they differ, both of these online programs contain information about ms and fatigue intended to help people with ms understand and manage their fatigue. this large-scale, decentralized clinical trial is projected to enroll 2,000 people with ms. the collaboration between iconquerms and 5 veterans affairs (va) sites in the ms centers of excellence is designed to ensure sufficient representation of people with ms from populations traditionally under-represented in ms clinical trials. the study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. two of the trial arms will include one of two online programs for managing fatigue in ms added to the trial participants' usual ms treatment, and the third arm will include usual ms treatment alone. the online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. participants in the usual ms treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.


Eligibility criteria:
inclusion criteria: * informed consent by person with ms * living in the us * age ≥ 22 * confirmed diagnosis of ms by a physician, who is a neurologist or has access to a neurologist's statement of diagnosis * fatigue severity scale score at or above eligibility threshold * fluent in english * willingness to engage in self-administration of an online intervention for 24 weeks and complete follow-up assessments * access to the internet and e-mail with a compatible device (smartphone, computer, or tablet) * no ms relapse / no steroid treatment in the 4 weeks prior to answering the screening questionnaire (self-reported) * no disease-modifying therapeutic (dmt) started in the 4 weeks prior to answering the screening questionnaire (self-reported) exclusion criteria: * unwilling or unable to consent * refusal to saving, processing and forwarding of pseudonymized data * concurrent participation in another interventional trial
a clinical study for comparison of the effects between gasless laparoscopy and conventional laparoscopy for distal gastric cancer

Conditions: Gastrectomy; Laparoscopy

Summary: the aim of this trial is to confirm the non-inferiority of gasless laparoscopy-assisted distal d2 radical gastrectomy to the conventional laparoscopy-assisted distal d2 radical gastrectomy for the treatment of advanced gastric cancer patients (t2-4a, n0-3, m0).

the primary end point was operative time for gasless laparoscopy-assisted distal d2 radical gastrectomy and conventional laparoscopy-assisted distal d2 radical gastrectomy. the secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for d2 radical gastrectomy.

Eligibility criteria:
inclusion criteria: 1. age \>18 and \<75 years old; 2. the gastric primary lesion is diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathologic techniques (papillary adenocarcinoma \[pap\], tubular adenocarcinoma \[tub\], mucinous adenocarcinoma \[muc\], signet ring cell carcinoma \[sig\], and poorly differentiated adenocarcinoma \[por\]); 3. preoperative clinical staging of t2-4a, n0-3, m0 (see preoperative assessment program; tumor staging is in accordance with ajcc-7th tnm); 4. it is expected that r0 surgical results will be obtained by distal subtotal gastrectomy and d2 lymph node dissection (also applies to multiple primary tumors) 5. preoperative ecog status score of 0/1; 6. preoperative asa (american society of anesthesiology) class of i -iii; 7. patients signed informed consent. exclusion criteria: 1. pregnant or lactating women; 2. serious mental illness; 3. history of abdominal surgery (except for laparoscopic cholecystectomy); 4. history of gastric surgery (including esd/emr for gastric cancer); 5. preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm) 6. other malignant disease history within five (5) years; 7. patients who received or were recommended a new adjuvant therapy; 8. history of unstable angina or myocardial infarction within six (6) months; 9. history of cerebral infarction or cerebral hemorrhage within six (6) months; 10. history of sustained systemic corticosteroid therapy within one (1) month; 11. patients requiring simultaneous surgical treatment of other diseases; 12. gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery; 13. pulmonary function test with fev1 \<50% of the expected value.

Keywords: laparoscopy-assisted gastrectomy gastric cancer
a study of the experience of music therapy in cancer patients with delirium

Conditions: Cancer Patients With Delirium

Summary: the purpose of this study is to improve our understanding of the experience of music therapy by cancer patients with delirium, and the experience of music therapists working with these patients. the researchers are focusing on patients with delirium because of the challenging symptoms of this condition. at msk, music therapy is routinely used in patients with cancer. music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.


Eligibility criteria:
inclusion criteria: * adult patients (ages 18-75) with delirium * referred for and receive music therapy. * were identified as having delirium by the confusion assessment method (cam), confusion assessment method for icu patients (cam-icu) or a documented diagnosis by a clinician from the department of psychiatry and behavioral sciences in the patient's electronic medical record (emr). * patients that have had music therapy in the past will be eligible for the study * only patients that recover from delirium (per cam, cam-icu, or progress note by a clinician from the department of psychiatry and behavioral sciences) after receiving music therapy will be approached for interview by the researcher. this study will also include their caregivers, music therapists, primary nurse, and bedside companions who have participated in or observed the participants' response to music therapy. the music therapist participants are: * board-certified senior music therapists with 10 or more years experience in the research site who sign a blanket consent form to participate in study. * assigned to eligible patients by integrative medicine service client service representative (csr). the caregivers are: * family or unrelated adult (\>18) caregivers who observed bedside music therapy session(s) with patients meeting inclusion criteria the staff caregivers are: * primary nurse caring for eligible patients who receive their first music therapy session while experiencing delirium. * patient care technicians (pct) assigned as bedside companions for eligible patients who receive music therapy exclusion criteria: * have a known hearing impairment * do not speak english. * are heavily sedated, comatose, or expected to be discharged or expire within 48 hours * have known comorbidities of delirium tremens, steroid psychosis, or dementia caregivers will be excluded from the study if they do not speak english. music therapists, nurses, or bedside companions will be excluded if they are not assigned to eligible patients.

Keywords: music therapy 19-270
observational study of c. diff in post-transplant patients

Conditions: Clostridium Difficile

Summary: the primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of c. difficile infections (cdi) in adult transplant recipients.

the primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of c. difficile infections (cdi) in adult transplant recipients. this includes treatment success, recurrence, and complications in a prospectively followed cohort of solid organ and hematopoietic stem cell transplant patients. patients who develop cdi within 2 years after transplantation will be enrolled and followed prospectively for 90 days after enrollment. specimens of stool and serum collected within 48 hours of initiation of treatment will be stored locally for future epidemiologic studies to examine the immunologic and microbiologic risk factors for relapse and treatment failure, as well as complications of cdi in the transplant population. response rates will be classified by organ type, hematopoietic stem cell transplant typ, treatment regimen, and immunosuppressive regimen.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed informed consent * transplant recipient (solid organ, stem cells, or bone marrow) within past 2 years * currently diagnosed with first cdi after transplant, defined by (1) presence of diarrhea (at least 3 loose stools within a 24-hour period), and (2) detection of c. difficile cytotoxin in stools by cytotoxin assay, or toxigenic culture, or polymerase chain reaction (pcr) testing for toxin, or enzyme immunoassay, or endoscopic presence of pseudomembranes with the detection of c. difficile in tissue biopsies exclusion criteria: * previous episode of cdi anytime after transplant * current treatment for another infectious cause of diarrhea (bacterial, viral, or parasitic) at the time of the current cdi diagnosis

Keywords: transplant
efficacy of romiplostim in treatment of saa in adults previously untreated with or refractory to immunosuppressive therapy

Conditions: Severe Aplastic Anemia (SAA)

Summary: romiplostim has been used in clinical trials for the treatment of severe and very severe aplastic anemia (saa/vsaa) in asian participants who are either previously untreated with immunosuppressive therapy (ist) or refractory to ist. this study will evaluate the efficacy of romiplostim in the treatment of participants with saa/vsaa. the primary objectives of this study are to: arm 1: evaluate the efficacy of romiplostim and ist in adult saa/vsaa participants who are previously untreated with ist (1l) arm 2: evaluate the efficacy of romiplostim treatment in adult saa/vsaa participants who are refractory to ist (2l+)


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at time of enrollment * diagnosis of saa/vsaa confirmed by blood, bone marrow, and cytogenetic studies * an eastern cooperative oncology group (ecog) performance status score of 0 to 1 at screening * arm 1 only: participant requires initial treatment for saa/vsaa, no matched related donor is available for allogenic hematopoietic cell transplantation (hct) and will begin ist with antithymocyte globulin and csa * arm 2 only: refractory to at least one course of immunosuppressive therapy including horse or rabbit atg; or ineligible for atg treatment and refractory to csa exclusion criteria: * diagnosed as having congenital aplastic anemia (aa) (fanconi anemia, congenital dyskeratosis, etc) * history of other malignancy within the past 5 years, with exceptions. * aplastic anemia with hemolytic paroxysmal nocturnal hemoglobinuria (pnh) (hemolytic predominant is defined as lactate dehydrogenase (ldh) \> 1.5 x the upper limit of site normal * arm 1 only: previously treated with atg, csa, or alemtuzumab * previously treated with pegylated recombinant human megakaryocyte growth and development factor (peg-rhumgdf), recombinant human thrombopoietin protein (tpo), romiplostim and other tpo-receptor agonist (eltrombopag, etc) * patients who are eligible for allogenic hct and have an available matched related donor

Keywords: severe aplastic anemia saa very severe aplastic anemia vsaa romiplostim
linagliptin and mesenchymal stem cells: a pilot study

Conditions: Schizophrenia

Summary: the purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of sdf1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting.

this study is a 13-week, open-label study of 8 participants with schizophrenia and minimal thought disorder; they will have 12 weeks of treatment and week for assessment. they will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. the principal outcome measures will be the concentrations of the long and short forms of sdf1-α (stromal cell-derived factor alpha) in blood.

Eligibility criteria:
inclusion criteria: * meets dsm (diagnostic and statistical manual) criteria for schizophrenia. * considered clinically stable, and on the same dose of antipsychotic for two weeks. * a score no greater than 3 on the panss (positive and negative syndrome scale) conceptual disorganization item. * not taking any medications for diabetes, or any anti-inflammatories other than occasional aspirin or acetaminophen. not taking clozapine. * age 18-45 years. * can be available for regular morning appointments from 8:00 am to 10:00 am, preferably on tuesdays, wednesdays and thursdays. exclusion criteria: * does not meet dsm criteria for substance abuse or dependence. * no serious current general medical condition, such as cancer, history of stroke or myocardial infarction, tuberculosis, hiv/aids, hemophilia, etc.

Keywords: dpp-4 inhibitor linagliptin sdf1-α
tribal health and resilience in vulnerable environments

Conditions: Obesity

Summary: the thrive study is a healthy retail intervention that improves the food environments in tribally owned and operated convenience stores in the chickasaw nation and choctaw nation of oklahoma.

the thrive study is a cluster randomized trial, using a community-based participatory research approach, of "healthy makeovers" in eight convenience stores owned and operated by the chickasaw nation and choctaw nation of oklahoma. the study will test the ability of tribal nations to increase fruit and vegetable purchasing and consumption among tribal members through environmental and policy approaches. investigators hypothesize that tribal members exposed to the highest doses of the intervention (i.e. those who visit the intervention convenience stores the most) will increase their fruit and vegetable intake. individual-level changes in fruit and vegetable intake will be measured via a survey administered to a cohort of 1600 american indian shoppers before and after the intervention. a multimedia manual, website, and documentary film will be created as part of the implementation of thrive to engage tribal citizens, enhance local knowledge, and guide other tribes to improve their food and physical activity environments.

Eligibility criteria:
inclusion criteria * american indian or alaska native * residing in the tribal jurisdictional areas * no plans of moving within 12 months * self-report shopping at the stores for food at least 3 times per week exclusion criteria: • anyone who does not meet these criteria